A Study to Determine the Seroprevalence of Bordetella Pertussis in Adults in Hungary

N/ACompletedNCT02014519

GlaxoSmithKline2,000 enrolled

Overview

The purpose of this study is to perform an epidemiological survey of the adult population in Hungary to calculate the seroprevalence of pertussis.

The protocol posting was amended to correct the detailed title. Since a sample of blood will be collected from all subjects (outside of routine hospital procedure), the study does not meet GSK's definition of an observational study and hence the term "observational" was deleted from the detailed title.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

2,000

Conditions

Pertussis Pertussis Vaccines

Interventions

Blood samplingPROCEDURE

A blood sample (2.5 mL) will be collected from all subjects

Data collectionOTHER

Active questioning

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects who the investigator believes can and will comply with the requirements of the protocol. * Written informed consent will be obtained from subjects prior to performing any study procedures. * Males or females ≥ 18 years of age at the time of enrollment. * Agreeing to collection of a blood sample for the study. Exclusion Criteria: • Confirmed or suspected immunological disorder.

Locations (5)

GSK Investigational Site

Budapest, Hungary

GSK Investigational Site

Budapest, Hungary

GSK Investigational Site

Debrecen, Hungary

GSK Investigational Site

Kecskemét, Hungary

GSK Investigational Site

Outcomes

Primary Outcomes

Number of Seropositive Subjects in Terms of Anti-pertussis Toxin (Anti-PT) Concentrations

Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (\> 0.3 Optical Density (OD) units)

Time frame: At the time of enrollment of each subject (Day 0)

Number of Subjects With Anti-PT IgG Levels Strongly Indicative of Current/Recent Infection

The cut-off value for anti-PT IgG levels strongly indicative of current/recent infection was greater than or equal to (≥) 1.5 OD units

Time frame: At the time of enrollment of each subject (Day 0)

Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection

The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units.

Time frame: At the time of enrollment of each subject (Day 0)

Number of Seronegative Subjects in Terms of Anti-PT Concentrations

Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units)

Time frame: At the time of enrollment of each subject (Day 0)

Secondary Outcomes

Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Age)

Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (\> 0.3 OD units).

Time frame: At the time of enrollment of each subject (Day 0).

Number of Subjects With Anti-PT IgG Levels Strongly Indicative of Current/Recent Infection (by Age)

The cut-off value for anti-PT IgG levels strongly indicative of current/recent infection was greater than or equal to (≥) 1.5 OD units

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Time frame: At the time of enrollment of each subject (Day 0)

Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Age)

The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units.

Time frame: At the time of enrollment of each subject (Day 0)

Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Age)

Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units)

Time frame: At the time of enrollment of each subject (Day 0)

Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Gender)

Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (\> 0.3 OD units)

Time frame: At the time of enrollment of each subject (Day 0)

Number of Subjects With Anti-PT IgG Levels Strongly Indicative of Current/Recent Infection (by Gender)

The cut-off value for anti-PT IgG levels strongly indicative of current/recent infection was greater than or equal to (≥) 1.5 OD units

Time frame: At the time of enrollment of each subject (Day 0)

Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Gender)

The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units.

Time frame: At the time of enrollment of each subject (Day 0)

Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Gender)

Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units)

Time frame: At the time of enrollment of each subject (Day 0)

Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Gender)

The cut-off value for anti-PT IgG levels not indicative of current/recent infection was smaller than (\<) 1.0 OD units.

Time frame: At the time of enrollment of each subject (Day 0)

Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Recent History of Long-lasting Cough)

Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (\> 0.3 OD units). A long-lasting cough was defined as any cough that lasted for more than (≥) 3 weeks in the previous 12 months.

Time frame: At the time of enrollment of each subject (Day 0)

Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Recent History of Long-lasting Cough)

Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units). A long-lasting cough was defined as any cough that lasted for more than (≥) 3 weeks in the previous 12 months.

Time frame: At the time of enrollment of each subject (Day 0)

Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Recent History of Long-lasting Cough)

The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units. A long-lasting cough was defined as any cough that lasted for more than (≥) 3 weeks in the previous 12 months.

Time frame: At the time of enrollment of each subject (Day 0)

Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Recent History of Long-lasting Cough)

The cut-off value for anti-PT IgG levels not indicative of current/recent infection was smaller than (\<) 1.0 OD units. A long-lasting cough was defined as any cough that lasted for more than (≥) 3 weeks in the previous 12 months.

Time frame: At the time of enrollment of each subject (Day 0)

Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Smoking Status)

Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (\> 0.3 OD units)

Time frame: At the time of enrollment of each subject (Day 0)

Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Smoking Status)

Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units)

Time frame: At the time of enrollment of each subject (Day 0)

Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Smoking Status)

The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units.

Time frame: At the time of enrollment of each subject (Day 0)

Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Smoking Status)

The cut-off value for anti-PT IgG levels not indicative of current/recent infection was smaller than (\<) 1.0 OD units.

Time frame: At the time of enrollment of each subject (Day 0)

Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by History of Pertussis)

Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (\> 0.3 OD units)

Time frame: At the time of enrollment of each subject (Day 0)

Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by History of Pertussis)

Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units)

Time frame: At the time of enrollment of each subject (Day 0)

Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by History of Pertussis)

The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units.

Time frame: At the time of enrollment of each subject (Day 0)

Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by History of Pertussis)

The cut-off value for anti-PT IgG levels not indicative of current/recent infection was smaller than (\<) 1.0 OD units.

Time frame: At the time of enrollment of each subject (Day 0)

Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by History of Vaccination Against Pertussis)

Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (\> 0.3 OD units)

Time frame: At the time of enrollment of each subject (Day 0)

Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by History of Vaccination Against Pertussis)

Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units)

Time frame: At the time of enrollment of each subject (Day 0)

Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by History of Vaccination Against Pertussis)

The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units.

Time frame: At the time of enrollment of each subject (Day 0)

Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by History of Vaccination Against Pertussis)

The cut-off value for anti-PT IgG levels indicative of current/recent infection was smaller than (\<) 1.0 OD units.

Time frame: At the time of enrollment of each subject (Day 0)

Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Medication)

Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (\> 0.3 OD units). Medication included any antibiotics and/or other medication (i.e. any cough medicines) for lower respiratory tract infections, Pertussis infections or suspected Pertussis infections in the previous 12 months.

Time frame: At the time of enrollment of each subject (Day 0)

Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Medication)

Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units). Medication included any antibiotics and/or other medication (i.e. any cough medicines) for lower respiratory tract infections, Pertussis infections or suspected Pertussis infections in the previous 12 months.

Time frame: At the time of enrollment of each subject (Day 0)

Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Medication)

The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units. Medication included any antibiotics and/or other medication (i.e. any cough medicines) for lower respiratory tract infections, Pertussis infections or suspected Pertussis infections in the previous 12 months.

Time frame: At the time of enrollment of each subject (Day 0)

Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Medication)

The cut-off value for anti-PT IgG levels indicative of current/recent infection was smaller than (\<) 1.0 OD units. Medication included any antibiotics and/or other medication (i.e. any cough medicines) for lower respiratory tract infections, Pertussis infections or suspected Pertussis infections in the previous 12 months.

Time frame: At the time of enrollment of each subject (Day 0)

Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Hospitalization)

Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (\> 0.3 OD units). History of hospitalization was defined as hospitalization due to respiratory infections in the previous 12 months.

Time frame: At the time of enrollment of each subject (Day 0)

Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Hospitalization)

Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units). History of hospitalization was defined as hospitalization due to respiratory infections in the previous 12 months.

Time frame: At the time of enrollment of each subject (Day 0)

Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Hospitalization)

The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units. History of hospitalization was defined as hospitalization due to respiratory infections in the previous 12 months.

Time frame: At the time of enrollment of each subject (Day 0)

Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Hospitalization)

The cut-off value for anti-PT IgG levels not indicative of current/recent infection was smaller than (\<) 1.0 OD units. History of hospitalization was defined as hospitalization due to respiratory infections in the previous 12 months.

Time frame: At the time of enrollment of each subject (Day 0)